Pipeline

A unique understanding of time-dependent biological processes informs everything we innovate for the treatment of chronic neurologic disorders. We continue to search for time-dependent patterns in diseases to reshape medicines and drive improved clinical outcomes for people in need.

Our medicines are timed for the benefit of patients.

ADS-5102 (amantadine) extended-release capsules

Multiple Sclerosis: Walking Impairment

Multiple sclerosis (MS) is a chronic autoimmune-mediated disorder that affects approximately 400,000 people in the United States.1 Walking impairment is a central feature of MS progression.2,3,4 The reported prevalence of impaired mobility due to MS ranges from 50% to over 90% of patients.1 As also reported in Parkinson’s disease, dysregulation of the NMDA receptor has been associated with the symptomology of MS,5 therefore symptoms may be improved by modulating overactivated NMDA receptor signaling. In addition, the impact of walking impairment and related symptoms (eg, fatigue, depression, and cognition) is most profound during the daytime when MS patients are engaged in activities of daily living.6,7 As a result, an effective treatment should provide relief beginning in the morning, and be sustained throughout the day, while not disrupting sleep.

ADS-5102, a high-dose amantadine investigational agent taken once-daily at bedtime, was designed to provide a slow initial rate-of-rise in drug concentrations and a delayed time to the maximum concentration.

We completed a Phase 2 proof-of-concept study evaluating ADS-5102 in patients with MS who have walking impairment. In the study, patients treated with ADS-5102 showed a significant improvement in walking speed as assessed by the Timed 25 Foot Walk (T25FW) test and an improvement in the Timed Up and Go (TUG). In addition, ADS-5102 was generally well tolerated.

Based on the positive Phase 2 data, we’ve initiated a pivotal registration program. Our Phase 3 program is planned to consist of two Phase 3 studies, a pivotal efficacy and safety study, and an open label safety study. We are also completing non-clinical studies to support the approval in this multiple sclerosis population. If the first pivotal Phase 3 study is successful, we intend to meet with the FDA to confirm the filing requirements for this supplemental NDA.

ADS-5102 References: 1. Sutliff, M. H. Contribution of impaired mobility to patient burden in multiple sclerosis. Curr Med Res Opin; 2010 26(1): 109-119. 2. Kurtzke, J. F. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS) and Form. Neurology; 1983 33(11):1444-1452. 3. Cohen, R. A., H. R. Kessler, et al. The Extended Disability Status Scale (EDSS) as a predictor of impairments of functional activities of daily living in multiple sclerosis. J Neurol Sci; 1993 115(2):132-135. 4. Hobart, J. C., A. Riazi, et al. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology; 2003 60(1):31-36. 5. Rossi, S., V. Studer, et al. Opposite roles of NMDA receptors in relapsing and primary progressive multiple sclerosis. PLoS One; 2013 8(6):e67357. 6. Cohen, R.A., and M. Fisher. Amantadine Treatment of Fatigue Associated with Multiple Sclerosis. Arch Neurol; 1989; 46:676-680. 7. Socie, M.J., et. al. Gait variability and disability in multiple sclerosis. Gait & Posture; 2013 38:1-55.

ADS-4101 (lacosamide)
modified-release capsules

Epilepsy: Partial-onset Seizures

Epilepsy affects an estimated 2.2 million Americans, of which 60% have partial onset seizures.1,2 Monotherapy treatment of partial seizures is effective in approximately 60% of patients, leaving the remainder of patients to require adjunctive treatment with one or more additional anticonvulsant therapies.3,4 There are limited data on the temporal distribution of seizures over the 24-hour day, however, published studies suggest that seizures occur in a diurnal pattern, characterized by a peak between 8 AM and 4 PM, and lowest between midnight and 8 AM.5 Thus, by matching the timing pattern of seizures to the concentration of the anti-epileptic drug, with a higher drug concentration during the day and lower drug concentration during the night, may enable improved seizure control.

Clinical studies of lacosamide, an anti-epilepsy active ingredient previously approved by the U.S. Food and Drug Administration (FDA) and currently marketed by UCB, Inc. as VIMPAT® (lacosamide), have reported dose limitations due to dizziness immediately following administration.6 We hypothesized the dizziness associated with higher doses might be in part attributed to the rapid initial rate-of-rise in drug concentration. Adamas scientists confirmed this time-dependent effect through in vivo modeling and preclinical experiments, showing that tolerability was dependent on rate-of-rise of drug concentration and not on maximum concentrations (Cmax).

ADS-4101, a high-dose lacosamide investigational agent taken once-daily at bedtime, was designed to have a slow initial rate-of-rise in lacosamide concentrations, to potentially improve the adverse event profile. This slow initial rise may enable a higher once-daily bedtime dose, potentially resulting in a higher daytime concentration than VIMPAT.

We have completed two Phase 1 studies of ADS-4101 in healthy volunteers. The Phase 1a study showed that a single 400 mg dose of ADS-4101 was better tolerated compared to the equivalent dose of VIMPAT immediate release tablets. The data also demonstrated that ADS-4101 exhibited the desired pharmacokinetic properties, namely a reduced rate of initial rise and delayed time to maximum drug concentration appropriate for bedtime dosing. The recently completed and reported results of a multi-dose Phase 1b study demonstrated that a 600mg dose of ADS-4101, taken once-nightly, provided a 1.5 to 2.5-fold increase in average lacosamide concentrations throughout the day compared to the maximum approved daily dose of 400 mg, taken as 200 mg twice-daily (BID), of VIMPAT immediate release tablets in healthy volunteers, with comparable tolerability.

We expect to meet with the FDA in an End-of-Phase 2 meeting regarding our planned Phase 3, pivotal program for ADS-4101 in the first half of 2018. Our proposed clinical development program includes two Phase 3 studies: a robust pivotal study comparing 400 mg and 600 mg of ADS-4101 to placebo, as well as the active comparator, VIMPAT, and an open-label extension study. Subject to the feedback from the FDA, we anticipate that the Phase 3 study would enroll starting in 2019 and complete enrollment in 2020. The timing of the ADS-4101 clinical development program and its potential approval in the United States is planned to allow us to optimize ADS-4101’s intellectual property protections and market opportunity.

ADS-4101 References: 1. Hirtz, D., Thurman, DJ., et al. How common are the “common” neurological disorders? Neurology; 2007 68:326-337. 2. Tellez-Zenteno, JF., Ronquillo LH., et al. Discontinuation of antiepileptic drugs after successful epilepsy surgery. Epilepsy Res; 2012 102(1-2):23-33. 3. Kwan, P. B., M. J. Early identification of refractory epilepsy. N Engl J Med; 2000 42(5):314-319. 4. Brodie, M. J., S. J. Barry, et al. Patterns of treatment response in newly diagnosed epilepsy. Neurology; 2012 78(20):1548-1554. 5. Hofstra, W. A., B. E. Grootemarsink, et al. Temporal distribution of clinical seizures over the 24-h day: a retrospective observational study in a tertiary epilepsy clinic. Epilepsia; 2009 50(9):2019-2026. 6. Horstmann, R., R. Bonn, et al. Basic Clinical Pharmacologic Investigations of the New Antiepileptic Drug SPM 927. Epilepsia; 2002 43(S7).

Counsel / Senior Counsel, Healthcare Law

The Counsel / Senior Counsel, Healthcare Law, will support legal matters related to the strategy and execution of commercial, medical, and clinical activities. This position reports to the Assistant General Counsel and is expected to work closely with other members of the legal and compliance group, as well as executive, commercial, medical, regulatory, and clinical teams.  This position is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Desktop Engineer, Information Technology

The Desktop Engineer is responsible for developing, deploying, and managing end user’s systems security, automation, software deployment, software patch remediation and device management in addition to providing escalated helpdesk support to internal users. This position will be tasked with creating functional deliverables, such as; testing plans/scripts, creating training plans and on-boarding manuals, identifying gaps, and providing solutions to IT related matters. This position reports to the Senior Manager, IT Operations and is located in Emeryville, California.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Director, Channel and Patient Services Strategy and Operations

The Director of Channel and Patient Services Strategy and Operations will be responsible for the management of the commercial organization’s specialty distribution and dispensing channel strategy and patient services strategy, including the development and evaluation of performance-based metrics related to the deployment of such strategies in collaboration with channel intermediaries and service providers. This position will support the commercialization and channel strategies of Adamas’ first commercial product, Gocovri™ through the relationship and oversight of Gocovri™ Onboard, exclusive specialty pharmacy provider (SPP) relationship, and specialty distributor relationships. As a member of the commercial team, this position will work across the organization and commercial functions to ensure patient access support is in alignment with brand team deliverables that support the execution of commercial launch and growth plans. This position reports to the SVP of Market Access, Distribution, and Commercial Operations and may be based in Emeryville, CA or remotely, based on approval from Adamas™ Executive Leadership.

Specific Responsibilities:

Qualifications:

Competencies:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Director, Commercial Operations

The Director, Commercial Operations partners with the Commercial Organization to drive and measure performance by providing subject matter expertise, leadership and insights with a primary focus on Reporting, Incentive Compensation, and CRM/DW/MDM. This position reports to the Vice President, Commercial Operations and is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

Competencies:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Director, Quality Assurance

The Director, Quality Assurance is responsible for all aspects quality assurance and GxP compliance. The Director, Quality Assurance will establish quality plans and policies and report to Quality Management on a regular basis on compliance activities and findings. This position will design, implement and maintain QA and compliance programs and infrastructure including a SOP system, training program, and perform internal and external audits. The Director, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. This position will serve as an in-house advisor on GxP compliance and report to the Vice President, Quality Assurance and is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Manager / Senior Manager, Commercial Finance (Financial Planning and Analysis)

The Manager/ Senior Manager, Commercial Finance (FP&A) is primarily responsible for providing strategic and financial leadership to the organization’s Commercial function. The role will focus on the analytics that support strategic financial planning, budgets, forecasting, monthly close support, and project management. The role will be a hands-on resource to senior management, project/brand leads, and department heads. This position reports to the Sr. Director, FP&A and is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Manager / Senior Manager, Pharmaceutical Development

The Manager / Senior Manager, Pharmaceutical Development contributes to the drug product development process by developing formulations for preclinical and clinical evaluation.  It involves working collaboratively within a multidisciplinary framework within the organization and with external contract manufacturing organizations. This position reports to the Vice President, Pharmaceutical Development and is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Medical Director/ Senior Medical Director

The Medical Director / Senior Medical Director will be integrally involved in all aspects of clinical trial design and execution, including authoring of protocols, site initiation, and medical monitoring, as well as data interpretation and reporting. Position reports to Senior Vice President, Clinical Research and is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Medical Science Liaison (Southeast)

The Medical Science Liaison (MSL) is responsible for conducting medical/scientific interactions and for supporting internal activities related to medical communications, medical information and clinical research. This position reports to the Director, MSL Team and is a field based position with a corporate headquarters in Emeryville, California.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Payroll Administrator

The Payroll Administrator is responsible for all aspects of payroll processing, the daily activities of stock plan administration, and provides back-up support for the Accounts Payable team. The Payroll Administrator will ensure accurate and timely processing of semi-monthly and off-cycle payroll in Workday for approximately 200 multi-state employees, generate payroll accounting entries, ensure accurate tax calculation of employee stock option exercises and RSU vesting, process grants, and ensure timely and accurate payroll tax and stock government filings.  Additionally, this individual will routinely partner with others across multiple functions ensuring proper alignment with policies, controls and compliance with US GAAP. This position reports to the Senior Manager, Accounting and is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Senior Accountant

The Senior Accountant will have a critical role in maintaining accounting principles, practices, and procedures to ensure the timely/accurate preparation of financial statements. The Senior Accountant is responsible for preparation of journal entries and financial statement analysis to support key monthly deliverables. Areas of responsibility include but are not limited to analyzing, recording, and reconciling accounting transactions to support internal and external financial reporting. Additionally, this individual will routinely partner with others across multiple functions ensuring proper alignment with policies, controls and compliance with US GAAP. This position reports to the Senior Manager, Accounting and is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Sr. Project Manager / Associate Director, Product Planning

The Senior Project Manager/Associate Director Project Manager (PM) will drive critical execution objectives for compounds in all stages of development (early, late and commercial). This position requires excellent communication and leadership skills, in addition to a strong technical understanding of the inter-disciplinary nature of drug development. The individual will collaborate closely with the Project Team Leader (PTL) and team members. This position will report into the Vice President, Product Planning and is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Vice President, Business Development / Licensing

The Vice President, Business Development / Licensing will be responsible for business development, partnering and alliance management activities, including supporting operations, as required, and conducting product/market evaluations outside of the United States. The ideal candidate will be a business-minded strategic and operational leader who will bring strong corporate transaction, alliance management, analytical, and general operations expertise to Adamas. This individual will lead our internal and external business development and partnering activities, and collaborate with key functions to achieve Adamas’ objectives.  This position will report to the Chief Operating Officer.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Vice President, Statistical Science

The Vice President, Statistical Science, will build and oversee data management, biostatistics, and statistical programming for the clinical research, medical affairs, and research teams. This position will be the Company representative both internally and externally on all matters related to biometrics. This position will report to the Senior Vice President, Clinical Research and is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.